NCT02121613已完成4 期
PERMIXON® 160 mg Hard Capsule Versus Placebo in the Treatment of Symptomatic Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 833
- 主要终点
- International Prostate Symptom Score (I-PSS score) change
研究概览
简要总结
The aim of this study is to support the efficacy of Permixon 160 mg b.i.d. in treating subjects with symptomatic Benign Prostatic Hyperplasia (BPH), compared to placebo, using Tamsulosine LP 0.4 mg as a reference treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male subject
- •Between 45 and 85 years old
- •Subject with bothersome lower urinary tract symptoms (LUTS) due to BPH such as frequency (daytime or night time), urgency, sensation of incomplete voiding, delayed urination or weak stream
- •Subject naive to any prior treatment for LUTS due to BPH
- •Prostate enlargement at digital rectal examination (DRE) suggestive of BPH
- •I-PSS > 12 at enrolment visit and at inclusion visit
- •QoL I-PSS score ≥ 3 evaluated at enrolment visit and at inclusion visit
排除标准
- •Urological history such as urethral stricture disease and/or bladder neck disease, active (at enrolment and/or inclusion or recurrent urinary tract infection, stone in bladder or urethra)
- •Any neurologic or psychiatric disease/disorder interfering with detrusor or sphincter muscle
- •Insulin-dependent diabetes mellitus and non-controlled non insulin-dependent diabetes mellitus
- •Known severe renal insufficiency or creatinine clearance < 30 ml/mn
- •Known liver insufficiency or clinically significant abnormal liver function tests
- •History of, or concomitant, cardiac arrhythmia or angina pectoris
- •Orthostatic hypotension at enrolment or inclusion visit
- •Known hypersensitivity to one of the constituents of the study drugs
- •Is participating in another clinical trial
研究组 & 干预措施
Permixon® 160 mg & Placebo
Experimental
干预措施: Permixon® 160 mg (Drug)
Permixon® 160 mg & Placebo
Experimental
干预措施: Placebo matching Permixon® 160 mg (Drug)
Permixon® 160 mg & Placebo
Experimental
干预措施: Placebo matching Tamsulosine LP (Drug)
Placebo
Placebo Comparator
干预措施: Placebo matching Permixon® 160 mg (Drug)
Placebo
Placebo Comparator
干预措施: Placebo matching Tamsulosine LP (Drug)
Tamsulosine LP & Placebo
Other
Active control arm
干预措施: Tamsulosine LP (Drug)
Tamsulosine LP & Placebo
Other
Active control arm
干预措施: Placebo matching Permixon® 160 mg (Drug)
Tamsulosine LP & Placebo
Other
Active control arm
干预措施: Placebo matching Tamsulosine LP (Drug)
结局指标
主要结局
International Prostate Symptom Score (I-PSS score) change
时间窗: Day 180
I-PSS score change from baseline to D180
次要结局
未报告次要终点
研究者
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